May 23, 2023
The US Food and Drug Administration (FDA) has approved extended-release injection buprenorphine (Brixadi, Braeburn Inc) for the treatment of moderate to severe opioid use disorder (OUD). […]
May 23, 2023
The US Food and Drug Administration has approved avapritinib (AYVAKIT, Blueprint Medicines Corp) for the treatment of adults with indolent systemic mastocytosis. The new approval, which […]
May 22, 2023
The US Food and Drug Administration (FDA) today approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch […]
May 19, 2023
The FDA Gastrointestinal Drugs Advisory Committee on Friday voted against the accelerated approval of Intercept Pharmaceutical’s obeticholic acid (OCA) for treatment of nonalcoholic steatohepatitis (NASH) with […]
May 19, 2023
The US Food and Drug Administration (FDA) has approved the first-ever topical gene therapy, which will be used to treat wounds in patients 6 months of […]
May 19, 2023
The US Food and Drug Administration approved epcoritamab (DuoBody, AbbVie and GenMab) today for adults with relapsed/refractory diffuse large B-cell lymphoma following at least two lines […]
May 19, 2023
The US Food and Drug Administration (FDA) has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and […]
May 18, 2023
The US Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq, AbbVie) for adults with moderately to severely active Crohn’s […]
May 16, 2023
The US Food and Drug Administration (FDA) has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain […]